Director Of Quality Assurance/Quality Controls

1.) The Quality Assurance/Quality Control Director will develop, implement, and periodically evaluate programs, policies and procedures to ensure the organization’s production operations, from raw materials to finished products, meet the quality, integrity, and efficiency standards set by the organization, FDA and other outside agencies regulations.

2,) Directs and oversees the quality control and quality assurance departments and supervisory staff, including all training to ensure the familiarity by all members of team with correct formats and procedures for labeling as well as external environment and proposed US regulations / guidance.

3.) Directs and oversees all preparations and implementation of new standard operation procedures (SOP’s), Test Procedures, and Specifications.

4.) Directs and enforces GMP’s, GLP’s, and safety policies.

5.) Preparation of responses to Regulatory authorities, supplements, and amendments; participation in final company document review and corrections; preparation of additional information as needed.

6.) Lead and participate in all FDA audit activities.

7.) Develops and implements quality standard testing and evaluation processes.

8.) Provides regulatory oversight of changes in manufacturing facilities, processes, procedures, and testing methods.

9.) Keeps apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company and shares information accordingly to staff and executive management.

A.) ·Ability to train staff in all aspects of QA and QC Departments.

B.)Thorough understanding and experience of FDA, QSR, GMP’s and drug cGMP and ability to train staff to meet requirements.

C.) Thorough knowledge of 21 CFR 820.

D.) Thorough understanding of quality control and quality assurance standards and methodologies.

E.)Thorough understanding of manufacturing and production within the skin care manufacturing industry.

F.)Experience in USFDA and ISO auditing and ability to lead team to successful audits.

G.) Experience with designing and developing test cases based upon system specifications.

Education and Experience:

· Minimum bachelor’s degree in chemistry or related industrial, scientific, or Chemical Engineering;

Master’s degree highly preferred.

· Minimum 10 years of QA/QC experience in OTC drugs and cosmetic manufacturing or similar industry. IT CAN BE:(pharmaceutical, food and or consumer good manufacturing.

· Minimum 5 years direct Supervision of QA/QC team members

· Minimum 5-7 years of experience in leading company to maintain GMP, ISO and FDA Regulations

·Experience in cleaning validation, process validation and supply chain management.

·Certified ISO auditor preferred

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Base Salary Range $150K-180K; (other compensation medical, dental, vision; 4% match on 401K; negotiable paid time off; two weeks’ vacation; open enrollment in November, PTO and 8 holiday; Employer pays 80% of the health insurance plan for employee.

Relocation Package offered.

Employment Type

Full-time on-site position